On March 18, 19, 21, and 28, 2013, the U.S. Food and Drug Administration (FDA) conducted an investigation of your dairy operation located at 01498 Barnard Road, Charlevoix, Michigan 49720. This letter notifies you of the violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) that we found during our investigation of your operation. You can find the FD&C Act and its associated regulations on the Internet through links on FDA’s web page at www.fda.gov.

We found that you offered for sale an animal for slaughter as food that was adulterated. Under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii), a food is deemed to be adulterated if it bears or contains a new animal drug that is unsafe under section 512 of the FD&C Act, 21 U.S.C. 360b. Further, under section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4), a food is deemed to be adulterated if it has been held under insanitary conditions whereby it may have been rendered injurious to health.

Specifically, our investigation revealed that on or about August 15, 2012 you sold a dairy cow identified with brucellosis tag (b)(4) and back tag (b)(4) for slaughter as food. On or about August 16, 2012, (b)(4) slaughtered this animal. United States Department of Agriculture, Food Safety and Inspection Service (USDA/FSIS) analysis of tissue samples collected from this animal identified the presence of penicillin at a level of 0.19 parts per million (ppm) in the kidney. FDA has established a tolerance of 0.05 ppm for residues of penicillin in the edible tissues of cattle as codified in Title 21, Code of Federal Regulations (C.F.R.), Section 556.510 (21 C.F.R. 556.510). The presence of this drug in the edible tissue of this animal in this amount causes the food to be adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).

Our investigation also found that you hold animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply. For example, you failed to maintain complete treatment records. Food from animals held under such conditions is adulterated within the meaning of section 402(a)(4) of the FD&C Act, 21 U.S.C. 342(a)(4).

We also found that you adulterated the new animal drug, AGRI-CILLIN® (penicillin), NADA 065-010. Specifically, our investigation revealed that you did not use penicillin as directed by its approved labeling. Use of this drug in this manner is an extralabel use. See 21 C.F.R. 530.3(a).

The extralabel use of approved animal or human drugs in animals is allowed under the FD&C Act only if the extralabel use complies with sections 512(a)(4) and (5) of the FD&C Act, 21 U.S.C. 360b(a)(4) and (5), and 21 C.F.R. Part 530, including that the use must be by or on the lawful order of a licensed veterinarian within the context of a valid veterinarian/client/patient relationship.

Our investigation found that you administered penicillin to your dairy cows without following the dose, frequency of treatment and indications for use as stated in the approved labeling. Your extralabel use of penicillin was not under the supervision of a licensed veterinarian, in violation of 21 C.F.R. 530.11(a). Because your use of this drug was not in conformance with its approved labeling and did not comply with 21 C.F.R. Part 530, you caused the drug to be unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated within the meaning of section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5).

The above is not intended to be an all-inclusive list of violations. As a producer of animals offered for use as food, you are responsible for ensuring that your overall operation and the food you distribute is in compliance with the law.

You should take prompt action to correct the violations described in this letter and to establish procedures to ensure that these violations do not recur. Failure to do so may result in regulatory action without further notice such as seizure and/or injunction.

Our investigation also revealed that on or about May 11, 2003, you provided (b)(4) with a signed “LIVESTOCK OWNERS’ CERTIFICATE” stating that none of the livestock supplied to (b)(4) will have an illegal level of drug residues. This signed agreement covered the cow with brucellosis tag (b)(4) and back tag (b)(4) which was found to contain a violative residue of penicillin. Providing such a false guaranty is prohibited by section 301(h) of the FD&C Act, 21 U.S.C. 331(h). You should take appropriate actions to ensure that this violation does not recur.

We acknowledge receipt of your April 13, 2013, letter in response to the Form FDA 483 Inspectional Observations issued to you at the close of the above inspection. Your response states that you will monitor drugs that are administered, take tests on cows, and track withholding days. You also explained that you will administer the indicated dosage of drug unless recommended otherwise by the veterinarian and will administer it at the frequency specified on the label. You further stated that you will check with the veterinarian on the exact usage of penicillin and determine whether the drug should be used for the treatment of foot diseases. You state that you have implemented a new system that will include recording the route of administration and the year in which medication is used. In addition, you state that you will establish a routine check of all drug expiration dates and promptly remove and dispose of expired drugs. However, we were unable to verify the corrections identified in your response because no actual documentation of these corrections was provided. For example, your response did not include a copy of your new medication records or the new system you described.

You should notify this office in writing of the steps you have taken to bring your firm into compliance with the law within fifteen (15) working days of receiving this letter. Your response should include each step that has been taken or will be taken to correct the violations and prevent their recurrence. If corrective action cannot be completed within fifteen (15) working days of receiving this letter, state the reason for the delay and the time frame within which the corrections will be completed. Please include copies of any available documentation demonstrating that corrections have been made.

Your written response should be sent to Tina M. Pawlowski, Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, Michigan 48207. If you have any questions about this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by email at tina.pawlowski@fda.hhs.gov.